Infusion device with automatic insertion and introducer needle retraction

ABSTRACT

An infusion device (10) includes one or more of automatic insertion and retraction of an introducer needle (40) and catheter (28), introducer needle safety and extension set. The device (10) can further comprise a top-push button (16) activation feature, a side-push button (402) activation feature or a rotary-button (412) activation feature, and one or more of a manual interlock of an outer barrel and base, and a manual interlock for an extension set top and base. Packaging (500) for an integrated and/or removable inserter with activation button protection is also disclosed.

RELATED APPLICATIONS

This application is a division of currently pending U.S. patentapplication Ser. No. 15/278,863, filed Sep. 28, 2016, which is adivision of U.S. patent application Ser. No. 14/002,683, filed Dec. 6,2013, which is the U.S. National Stage of International Application No.PCT/US12/00068, filed on Feb. 8, 2012, which claims priority to U.S.Provisional Application No. 61/448,975, filed Mar. 3, 2011, and U.S.Provisional Application No. 61/441,258, filed Feb. 9, 2011, each ofthese applications being hereby incorporated by reference in theirentirety.

FIELD OF THE INVENTION

The present invention relates generally to medical infusion systems,such as an insulin infusion device with one or more of automaticinsertion and automatic retraction, needle safety, soft catheter andextension set. The system can further comprise a side-push buttonactivation feature or a rotary-button activation feature, and one ormore of a manual interlock of an outer barrel and base, and an extensionset top and base, a manual interlock for an extension set top and baseand packaging for an integrated and/or removable inserter for activationbutton protection.

BACKGROUND OF THE INVENTION

A large number of people, including those suffering from conditions suchas diabetes, use some form of infusion therapy, such as daily insulininfusions, to maintain close control of their glucose levels. Currently,there are two principal modes of daily insulin therapy. The first modeincludes syringes and insulin pens. These devices are simple to use andare relatively low in cost, but they require a needle stick at eachinjection, typically three to four times per day. The second modeincludes infusion pump therapy, which entails the purchase of an insulinpump that lasts for about three years. The initial cost of the pump canbe significant, but from a user perspective, the overwhelming majorityof patients who have used pumps prefer to remain with pumps for the restof their lives. This is because infusion pumps, although more complexthan syringes and pens, offer the advantages of continuous infusion ofinsulin, precision dosing and programmable delivery schedules. Thisresults in closer blood glucose control and an improved feeling ofwellness.

The use of an infusion pump requires the use of a disposable component,typically referred to as an infusion set or pump set, which conveys theinsulin from a reservoir within the pump into the skin of the user. Aninfusion set typically consists of a pump connector, a length of tubing,and a hub or base from which an infusion needle or a flexible cannulaextends. The hub or base has an adhesive which retains the base on theskin surface during use, which may be applied to the skin manually orwith the aid of a manual or automatic insertion device.

There are many available types of infusion sets, including steel needleinfusion sets and soft catheter sets. Soft catheter sets are typicallyinserted into a patient manually with the aid of a steel needleintroducer, which is removed from the patient after insertion to leavethe soft catheter in place. In another type of infusion set, amechanized insertion device is used to forcefully and rapidly insert theintroducer needle and catheter, remove the introducer, or both. Often,the insertion device is a separate, stand-alone unit that the user isrequired to carry and provide. Stand-alone inserters typically requirethe user to manually load a set and compress a spring of the inserter,which can result in catheter insertion failure when either the set orthe spring is not properly loaded or compressed.

In soft catheter sets, the introducer needle is completely removed fromthe infusion set before being connected to the insulin pump. One problemassociated with manually inserting and retracting the introducer needleis variability in the insertion and retraction force, speed, smoothnessand angle. This variability can lead to an increased rate of catheterinsertion failure.

Further, as noted above, the user typically must remove the introducerneedle after inserting the catheter. This exposes the user to accidentalneedle sticks from handling the removed introducer needle.

Accordingly, a need exists for infusion sets and insertion devices thatfacilitate insertion of the catheter, while reducing the number ofcomponents a user must carry and substantially preventing accidentalneedle sticks.

SUMMARY OF THE INVENTION

An object of the present invention is to substantially address the aboveand other concerns, and provide infusion sets and insertion devices thatfacilitate insertion of the catheter, while reducing the number ofcomponents a user must carry and substantially preventing accidentalneedle sticks.

Another object of the present invention is to provide an infusion devicewith one or more of automatic insertion and automatic retraction and asafety insulin catheter and extension set.

Another object of the present invention is to provide an infusion devicewith a side-push button activation feature.

Another object of the present invention is to provide an infusion devicewith a rotary-button activation feature.

Another object of the present invention is to provide an infusion devicewith a manual interlock of an outer barrel and base, and an extensionset top and base.

Another object of the present invention is to provide an infusion devicewith a manual interlock for an extension set top and base.

Another object of the present invention is to provide an infusion devicewith packaging for an integrated and/or removable inserter foractivation button protection.

These and other objects are substantially achieved by providing aninfusion device that includes one or more of automatic insertion andautomatic retraction, needle safety, soft catheter and extension set.The device can further comprise a top-push button activation feature, aside-push button activation feature or a rotary-button activationfeature, and one or more of a manual interlock of an outer barrel andbase, and a manual interlock for an extension set top and base.

BRIEF DESCRIPTION OF THE DRAWINGS

The various objects, advantages and novel features of the exemplaryembodiments of the present invention will be more readily appreciatedfrom the following detailed description when read in conjunction withthe appended drawings, in which:

FIG. 1 is a sectional view of an infusion device utilizing a top-pushbutton in accordance with a first embodiment of the present invention;

FIGS. 2-5 are views of the device of FIG. 1 during use;

FIGS. 6 and 7 are views of the top-push button of the device of FIG. 1incorporating a needle safety feature in accordance with an embodimentof the present invention;

FIG. 8 is a sectional view of the device of FIG. 1 incorporating aneedle safety feature in accordance with an embodiment of the presentinvention;

FIGS. 9-17 are views of the device of FIG. 8 during use;

FIG. 18 is a sectional view of an infusion device utilizing a top-pushbutton in accordance with a second embodiment of the present invention;

FIGS. 19-26 illustrate views of the device of FIG. 18 during use;

FIG. 27 illustrates additional features for use with the above or otherinfusion devices;

FIG. 28 illustrates views of a stabilizer for use with the above orother embodiments of the present invention;

FIG. 29 illustrates views of another stabilizer for use with the aboveor other embodiments of the present invention;

FIGS. 30A-30D illustrate views of a strain relief member for use withthe above or other embodiments of the present invention;

FIGS. 31A-31E illustrate views of a securing member for use with theabove or other embodiments of the present invention;

FIGS. 32A-32E show another embodiment in which the securing member canbe used with a set;

FIG. 33 illustrates views of a top-push button for use with the above orother embodiments of the present invention;

FIGS. 34A and 34B illustrate views of a pen-style actuator for use withthe above or other embodiments of the present invention;

FIGS. 35A-35B, 36A-36C, and 37 illustrate views of the device of FIG. 34during use;

FIGS. 38-41 illustrate views of an infusion device utilizing a side-pushbutton in accordance with a third embodiment of the present invention;

FIGS. 42-45 illustrate views of an infusion device utilizing a rotarybutton in accordance with a fourth embodiment of the present invention;

FIGS. 46-51 illustrate views of a manually-activated interlock for usewith the above or other embodiments of the present invention;

FIGS. 52-60 illustrate views of a secondary interlock for use with theabove or other embodiments of the present invention; and

FIGS. 61-67 illustrate views of a package for use with the above orother embodiments of the present invention.

Throughout the drawings, like reference numerals will be understood torefer to like parts, components and structures.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The exemplary embodiments of the present invention deliver insulin tothe subcutaneous layers of the skin via a standard insulin pump or othersimilar device. By utilizing an infusion device with one or more ofautomatic insertion and automatic retraction, needle safety, softcatheter and extension set, with either top, side or rotary activationand one or more interlocks, proper insertion and maintenance of theinserted catheter in the subcutaneous space is ensured, whilemaintaining a degree of comfort to the user. In each embodiment of thepresent invention described below, standard infusion set elements suchas connectors, infusion catheters, adhesives and hubs can be provided.

In a first exemplary embodiment of the present invention, the devicecomprises an infusion set and insertion device packaged as a singleunit, thereby eliminating the need to carry any additional accessoriesand avoid the difficulty associated with loading the infusion set ontothe insertion device at each use. FIG. 1 is a sectional view of a device10 in accordance with an embodiment of the present invention. The device10 comprises an outer barrel 12, a base 14 and a button 16. The base 14comprises at least one outer barrel retention tab 18 that is configuredto rotatably enter openings 20 in the base 14 and be captured at arotational position by shoulders 22 of the base 14. A drive spring 24,needle hub sear 26 and catheter 28 are disposed within the outer barrel12. The catheter 28 contains a septum 30, and has one or more catheteralignment and retention tabs 32 extending therefrom, to be captured andguided within one or more catheter alignment slots 34 within the outerbarrel 12. One or more needle hub sear slots 36 are also provided withinthe outer barrel 12.

The embodiment of the present invention can be provided with a skincontacting adhesive layer 15 such as a pressure sensitive adhesive(PSA), and an adhesive cover 17. Precise insertion is achieved byremoving the adhesive cover 17 and securing the infusion set to theinfusion site via the adhesive layer 15, which permits the user toactivate the inserter or place the catheter as described below at theproper alignment and depth. In doing so, the adhesive at or very nearthe insertion site secures the skin surface such that the introducerneedle and catheter, or in-dwelling catheter are driven into the skinsurface in a manner to minimize the risk of tenting at needle insertion.

In the loaded position shown in FIG. 1 , the outer barrel 14 isrotatably secured to the base 14 and the button 16 is extended from thetop of the device, the drive spring 24 is compressed, and the catheter28 is in a retracted position. The needle hub 38 and introducer needle40 are also retracted. In the unloaded position shown in FIG. 2 , thebutton 16 has been pressed and contacts the needle hub 38. As describedin greater detail below, the downward travel of the button 16 serves torotate the needle hub 38 such that the needle hub sear 26 becomesaligned with the needle hub sear slot 36. The device 10 is thenpermitted to activate as driven by the spring 24 such that theintroducer needle 40 and catheter 28 are inserted into the skin surface(not shown). Specifically, one or more button cam slots 42 shown in FIG.3 , rotate the needle hub 38 by guiding the rotational lugs 44 (see FIG.6 ) on the needle hub 38 as the button 16 is pressed down, so that theneedle hub sears 26 become aligned with the needle hub sear slots 36 andthe device 10 is permitted to activate.

After activating the device 10 as described above, and the introducerneedle 40 and catheter 28 are inserted into a skin surface, the userturns the outer barrel 12 of the device, which moves the catheteralignment/retention tab 32 into a locked position with the base 14. Thatis, the catheter alignment/retention tabs 32 enter the openings 20 to becaptured by the shoulders 22 of the base 14 as shown in FIG. 4 . Theturning motion also serves to release the barrel retention tabs 18 ofthe outer barrel 12 from the same openings 20 and shoulders 22 of thebase 14, leaving the base 14 as shown in FIG. 5 in condition forattachment of the tube set (not shown).

In yet another embodiment of the present invention, a needle safety canbe configured to operate with the above device, utilizing the sameactions and operations for deployment. For example, the button 16 isshown again in FIG. 6 to illustrate such a safety concept button cam indetail, in an inactivated position, and in FIG. 7 to illustrate anactivated position. FIGS. 6 and 7 show the rotational lugs 44 of theneedle hub 38 within the slots 42 of the button 16. To provide anautomatic safety shown in greater detail in FIG. 8 , the device 10 canfurther comprise an outer barrel cap 50, inner barrel cap 52, innerbarrel 54 and safety spring 56.

In this case, the rotation of the outer barrel 12 which serves to securethe catheter alignment/retention tabs 32 and release the barrelretention tabs 18 as described above, can also serve to move an innerbarrel retention tab 58 from an initial state where the inner barrelretention tab 58 is locked to the outer barrel 12 as shown in FIG. 8 ,to a position to release the safety. As the outer barrel 12 is turned,the inner barrel retention tab 58 is restrained so as not to rotate, andaligns with the release slot 60 in the outer barrel 12. The catheteralignment/retention tab 32 is engaged with the base 14 as describedabove. The outer barrel retention tab 18 is then disengaged from thebase 14. In FIG. 11 , the inner barrel retention tabs 58 are shownengaged with the outer barrel 12, and FIG. 12 illustrates the innerbarrel retention tabs 58 engaged with the outer barrel 12 in anactivated position. The inner barrel retention tabs 58 disengage theinstant before the needle safety activates, and once rotated to alignwith the trigger slot 60 in the outer barrel 12 as shown in FIG. 13 ,allows the needle safety to activate into the retracted position shownin FIG. 14 .

Further turning results in the disengagement of the outer barrelretention tabs 18 from the base 14 as shown in FIG. 15 , and moves thecatheter alignment/retention tab 32 into a locked position with the base14, leaving the base 14 in condition for attachment of the tube set asshown in FIG. 16 . The disposable launcher or inserter assembly can thenbe removed and discarded as shown in FIG. 17 .

In a second exemplary embodiment of the present invention, the deviceagain comprises an infusion set and insertion device packaged as asingle unit, thereby eliminating the need to carry any additionalaccessories and avoid the difficulty associated with loading theinfusion set onto the insertion device at each use. FIG. 18 is asectional view of a device 110 utilizing an inserter and set inaccordance with the second embodiment of the present invention. Thedevice 110 comprises an outer barrel 112, a base 114 and a button 116.The base 114 comprises at least one outer barrel retention tab 118 thatis configured to rotatably enter openings 120 in the base 114 and becaptured at a rotational position by shoulders 122 of the base 114 asdescribed above. A drive spring 124, flexible sear 126 and catheter 128are disposed within the outer barrel 112. The flexible sear of thesecond embodiment can be provided in a number of positions. For example,in the embodiment shown in FIGS. 18-20 , the flexible sear 126 issecured to the outer barrel 112 at a point 125. In the embodiment shownin FIGS. 21-23 , the flexible sear 136 is secured to the outer barrel112 at a point 135.

Disposed within the device 110, the catheter 128 contains a septum 130,and has one or more catheter alignment and retention tabs 132 extendingtherefrom, to be captured and guided within one or more catheteralignment slots 134 within the outer barrel 112. The push button 116further comprises one or more deflectable, inclined button cams 117 toengage, deflect and release the flexible sears 126 from a needle hub138. The needle hub 138 is provided with an introducer needle 140.

The embodiment of the present invention can be provided with a skincontacting adhesive layer 115 such as a pressure sensitive adhesive(PSA), and an adhesive cover 117. Precise insertion is achieved byremoving the adhesive cover 117 and securing the infusion set to theinfusion site via the adhesive layer 115, which permits the user toactivate the inserter or place the catheter as described below at theproper alignment and depth. In doing so, the adhesive at or very nearthe insertion site secures the skin surface such that the introducerneedle and catheter, or in-dwelling catheter are driven into the skinsurface in a manner to minimize the risk of tenting at needle insertion.

In the loaded position shown in FIG. 18 , the outer barrel 114 isrotatably secured to the base 114 and the button 116 is extended fromthe top of the device, the drive spring 124 is compressed, and thecatheter 128 is in a retracted position. The needle hub 138 andintroducer needle 140 are also retracted. In the unloaded position shownin FIG. 19 , the button 116 has been pressed and the deflectable,inclined button cams 117 engage, deflect and release the flexible sear126 from the needle hub 138. At this point, the device 110 is permittedto activate as driven by the spring 124 such that the introducer needle140 and catheter 128 are inserted into the skin surface as shown in FIG.20 .

After activating the device 110 as described above, the user turns theouter barrel 112 of the device which moves the catheteralignment/retention tab 132 into a locked position with the base 114.That is, the catheter alignment/retention tabs 132 enter the openings120 to be captured by the shoulders 122 of the base 114. The turningmotion also serves to release the barrel retention tabs 118 of the outerbarrel 112 from the same openings 120 and shoulders 122 of the base 114,leaving the base 114 in condition for attachment of the extension (tube)set. Further turning of the outer barrel 112 can activate a safety asdescribed above. FIG. 24 shows the safety 144 in greater detail.

Turning of the outer barrel 112 results in the disengagement of theouter barrel retention tabs 118 from the base 114, and moves thecatheter alignment/retention tab 132 into a locked position with thebase 114, leaving the base 114 in condition for attachment of theextension set 146 as shown in FIGS. 25 and 26 . The turning of the outerbarrel 112 also allows the needle safety to activate into the retractedposition shown in FIG. 24 substantially as described above. A bluntcannula 148 can be provided in the extension set connector to penetratethe septum 130 of the set as shown in FIG. 26 . The disposable launcheror inserter assembly can then be removed and discarded.

FIGS. 27-37 illustrate additional features for use with the above orother infusion devices. For example, a clocked inserter can be providedto secure and release an introducer needle 220 and catheter 224. FIG. 27illustrates a device 210 having a top cap 212, a button 214 and asterility/safety cap 216. A circular control member 218 is shown havingstops 219, and at least one clock 217, and is secured to a top of theintroducer needle 220. The circular control member 218 can be held inplace by stops 219, and released by aligning the clock 217 with thestops allowing downward movement of the circular control member 218 andintroducer needle 220.

Within the top cap 212, the introducer needle 220, septum 222, catheter224 and septum 226 are positioned beneath a drive spring 228. When thesafety cap 216 is removed, rotation of one or more of the elements usingthe top cap 212 or push button 214 can align the clock 217 with thestops allowing downward movement of the circular control member 218 andintroducer needle 220 for placement of the catheter 224. The device 210is configured to be very small, and to place the catheter 224 using, forexample, a reversed BD Autoguard™ inserter, and a 3M Tegaderm™-styleadhesive 232. The embodiment of the present invention can be providedwith a skin contacting adhesive layer 225 such as a pressure sensitiveadhesive (PSA), and an adhesive cover. Precise insertion is achieved byremoving the adhesive cover and securing the infusion set to theinfusion site via the adhesive layer 22, which permits the user toactivate the inserter or place the catheter at the proper alignment anddepth. In doing so, the adhesive at or very near the insertion sitesecures the skin surface such that the introducer needle and catheter,or in-dwelling catheter are driven into the skin surface in a manner tominimize the risk of tenting at needle insertion.

FIG. 28 illustrates another feature for use with the above or otherinfusion devices. Specifically, FIG. 28 illustrates views of a catheterstabilizer 250 for use with the above or other embodiments of thepresent invention. The catheter stabilizer 250 can be molded as aseparate part, using materials such as Vialon™, or stamped from foam orother similar materials. The catheter stabilizer 250 comprises aplurality of arms or stabilizers 252, one or more having an adhesive andbacking 254. A press-in catheter 256 can then be positioned within acentral opening 258 of the catheter stabilizer 250. The stabilizers 252can be adhesively secured to a surface to stabilize the catheter 256during use.

FIG. 29 illustrates views of another catheter stabilizer for use withthe above or other embodiments of the present invention. The catheterstabilizer 275 can be molded as a one-piece, molded catheter/hubstabilization part, using a polymeric material such as Teflon™ or BDVialon™ biomaterial, or stamped from foam or other similar materials.The catheter stabilizer 275 comprises a circular stabilizer 276 orplurality of wings 277, one or more having an adhesive and backing asdescribed above. A catheter 279 can be provided at a first side andopposite, a septum 278 can be positioned within a central opening 280 ofthe catheter stabilizer 275 to stabilize the catheter during use. Asshown in FIG. 29 , a manual inserter 282 or 284 can be used. The firstinserter 282 is an introducer needle and handle 282. The second inserter284 is shown having compressible handles 286 to move grasping arms 288at an opposite end, via a living hinge 290 therebetween. The graspingarms 288 can comprise snap features configured to grab similar featuresof a septum, hub and needle 292.

FIGS. 30A-30D illustrate views of an exemplary strain relief member foruse with the above or other exemplary embodiments of the presentinvention. The exemplary strain relief member of FIGS. 30A and 30Bcomprises a strap-type latch 300 that can be used with a set, such asthe exemplary set 306 and tube 304. The latch 300 can be adhesivelysecured to a skin surface some distance from the set 306, or can beincorporated with the set 306. Once in position, the tube 304 can bepressed into the latch 300, which serves to absorb any strain impartedon the tube 304.

FIGS. 30C and 30D also illustrate views of an exemplary rivet-type tubeset connector for use with the above or other exemplary embodiments ofthe present invention. The exemplary strain relief member comprises arivet connector 308 and a rivet receiving base 310. Such a set can use arivet connector 308 which is configured to expand a distal end whenpressed. The expanding distal end, if first placed into an opening ofthe base 310, secures the rivet 308 to the base 310. Specifically, therivet 308 can be proved with a slidable member 312 in a tube connectingend 314. When placed into a contoured opening 316 of the base 310,pressing the rivet 308 expands the tube connecting end in the opening316 of the base 310 to secure the tube 304 to the set. In such exemplaryembodiments, on or more of the elements can be secured using an adhesiveor covering 318, such as Tegaderm™.

FIGS. 31A-31E illustrate views of another securing member for use withthe above or other embodiments of the present invention. The securingmember 325 can be used with a set, such as the set 306 described above.The securing member 325 can comprise a spring 326 and an incline 328.The securing member 325 can be adhesively secured to a skin surface somedistance from the set 306, or can be incorporated with the set 306.Accordingly, as a set 306 is positioned as illustrated in FIG. 31B, theset 306 can contact the incline 328 such that the securing member 325 isdeflected to the side compressing the spring 326 as illustrated in FIG.31C, but returns to a position above the set 306 after placement asillustrated in FIG. 31D, such that the set 306 is secured. A deploymentdevice, such as a fuse-puller style device 320 as illustrated in FIG.31E can be used to defeat the securing member 325 to place or remove theset 306.

FIGS. 32A-32E show another embodiment in which the securing member 330can be used with a set, such as the set 306. The securing member 330 cancomprise a spring 334 and a shoulder 332 as illustrated in FIG. 32E. Thesecuring member 330 can be adhesively secured to a skin surface somedistance from the set 306, or can be incorporated with the set 306.Accordingly, as a set 306 is positioned as illustrated in FIGS. 32A and32B, the securing member 330 is deflected to the side by the inserterarms 336 as the arms move outward to release the set 306, therebycompressing the spring 334 as illustrated in FIGS. 32C and 32D. Thesecuring member 330 returns to a position above the set 306 afterplacement by the plunger 338 as illustrated in FIG. 32E, such that theset is secured.

FIG. 33 illustrates views of a top-push button for use with the above orother embodiments of the present invention. The button 350 can be usedwith a needle hub 352, and a trigger 354. The needle hub 352 comprisesan introducer needle 368, alignment pins 360 and pin 362 to engage anouter enclosure to prevent the needle hub 352 from rotating. The trigger354 comprises alignment pins 366 and pin 364 to engage a guide slot 356of the button. The button 350 is configured to be pushed downward intothe device, and comprises guide slots 356 with a pitch to rotate pin 364of the trigger 354 for releasing the needle hub 352. As the button 350is pushed, the trigger 354 is rotated and moves pins 366 from blockingpins 360 allowing the needle hub 352 to release and place the introducerneedle or in-dwelling catheter 368 into the skin surface. The button 350further comprises a pin 358 to engage the outer housing for furtherguidance and control of the button.

FIGS. 34A and 34B illustrate views of a pen-style actuator 375 for usewith the above or other embodiments of the present invention. Theactuator 375 comprises a drive spring 380, introducer needle 382, andseptum and/or catheter 384 as illustrated in FIG. 34A. The actuator 375can be positioned though a dome 376 which is configured to contain thecontents therein and place an outer adhesive ring 396 and an inneradhesive ring 394 beneath the septum 388. Two or more molded flexures386 can be provided between the adhesive rings 396 and 394, and betweena septum or U-shaped gasket 388 and a tubing connection 390. The dome376 is shaped and configured to flex, so as to be user-friendly.

The embodiment of the present invention can be provided with a skincontacting adhesive layers 394 and 396 such as a pressure sensitiveadhesive (PSA), and an adhesive cover 378. Precise insertion is achievedby removing the adhesive cover 378 and securing the infusion set to theinfusion site 385 via the adhesive layers 394 and 396, which permits theuser to activate the inserter or place the catheter as described belowat the proper alignment and depth. In doing so, the adhesive at or verynear the insertion site secures the skin surface such that theintroducer needle and catheter, or in-dwelling catheter are driven intothe skin surface in a manner to minimize the risk of tenting at needleinsertion.

In an exemplary use, the user removes an adhesive layer cover 378 andplaces the device on a skin surface 385. The actuator 375 can then beused to place the introducer needle 382 and catheter 384, or anin-dwelling catheter. The actuator 375 and dome 376 can then be removedwith the introducer needle. As noted above, the flexures 386 can beprovided between the adhesive rings 396 and 394, and between the septum388 and the tubing connection 390, and can comprise for example, moldedS-shaped members extending between the septum 388 of the inner ring tothe outer ring as more clearly shown in FIG. 37 . Accordingly, once thecatheter 384 is in place, the flexures 386 stabilize the outer adhesivering 396 to the inner adhesive ring 394 beneath the septum 388.

FIGS. 35A, 35B, 36A-36B and 37 illustrate views of the use of the deviceof FIG. 34 . In FIG. 35A, a top of the actuator 375 is pressed to deploythe introducer needle 382 and catheter 384 into the infusion site 385,and turning the actuator 375 releases the actuator and dome from the setas shown in FIG. 35B, leaving the catheter 384 within the septum 388 andremoving the introducer needle 382. FIGS. 36A-36C show views of theplacement of a tube set and cap system 392 with the set. The tube setand cap system 392 can be snapped into place with the set as illustratedin FIGS. 36A and 36B.

In one example, the cap 392 can comprise detents 395 to releasablycapture detents 398 of the set such that the cap 392 can be releasablysecured to the set as illustrated in FIG. 36B. Further, the cap 392 canbe provided with a blunt cannula connector 391 for completing a fluidconnection with the tubing connection 390. In such an embodiment, thereare fewer and better controlled insertion and connection steps, withlimited error points. Use is silent, with painless insertion due toscale. The embodiment also provides an integrated and disposableactuator for every tube set. The integrated inserter is slim, anddisposable, with a pen barrel-style, with a low-impact, activationmechanism. Further, the strain relief is provided by inner and outeradhesive rings coupled by flexures to decouple the catheter site fromthe tubing connection site as illustrated in FIG. 37 . Any tugs andpulls can break connections on the outer ring, but do not affect thecatheter site. The adhesive is placed on the skin surface first, whichminimizes tenting, improves stability and accuracy, and minimizeskinking at insertion. In yet other embodiments, the flexures 386 can beomitted so that the septum 388 is totally independent from outsidemovement. Further, the device comprises inherent dampening of motion dueto the completion of the fluid path with, for example, a U-shapedgasket.

In exemplary embodiments of the present invention, the housings, hubsand other elements can be constructed of molded plastic materials,polycarbonate, thermoplastic polymers such as polyethylene terephthalate(PET and PETG), or similar materials. Springs and introducer needles canbe constructed of stainless steel or similar materials. Although theembodiments described above are dimensioned and configured forsubcutaneous injection, they can also be used for other types ofinjection, such as intradermal or intramuscular injection.

In current infusion sets which deliver insulin or other medicament tothe subcutaneous layer, the catheter is not isolated from any undesiredoutside forces, which may cause pain when translated to the catheterwhich then moves within the skin. Also, other devices face problems ofpremature or unintended catheter removal when the device is bumped ifthe catheter is not isolated from the outside forces. In embodiments ofthe present invention, the catheter can be isolated from outside forcesby at least one flexible or resilient feature, or protected from outsideforces by at least one covering member.

As noted above, exemplary embodiments of the present invention provide acatheter and extension set for insulin infusion from an insulin pump orother medicament supply. The device is placed upon the skin surface of auser with adhesive, such as an adhesive layer disposed upon a basemember, then activated by pressing a button, whereupon insertion of theintroducer needle and catheter are performed manually or automaticallyusing energy supplied by a drive member, such as a drive spring. Removalof the introducer needle is also performed manually or automatically andthe introducer needle is retracted into the outer barrel where it islocked into place using for example, a latch, such that it cannot causeaccidental needle sticks when the launcher or inserter is removed fromthe base. The extension set is then attached to the base, and the fluidpath to the catheter is completed by a blunt cannula that pierces theseptum of the base. The exemplary system is then connected to aninfusion pump or other supply, and primed for use. In doing so, thedevice is configured to insert the catheter by pressing a button withoutrequiring the user to load the catheter into a launching device orinserter, or loading the launching device in some way by the user. Thedevice is further configured to retract the introducer needle and/orimplement other safety features.

Since the element being launched comprises only the catheter and needlehub subassembly, the mass is much smaller than what is launched withexisting devices. The effect of this is that the energy requirements ofthe device are less, leading to smaller, quieter devices, with furtheradvantages of being environmentally “greener” (i.e., requiring lessconstruction materials, construction steps, and generating less waste),and with less noise and impact upon activation. Further, since theadhesive layer is already in place on the skin surface of the user,manipulation of the adhesive after insertion of the catheter is lesslikely to occur and thereby eliminating a common cause of kinking of thecatheter.

Still further, exemplary embodiments are configured to be smaller thancomparative devices, yet accomplish both insertion and retraction of theintroducer needle. Further, because the device is packaged and shippedin an assembled and loaded state, there are inherently fewer pieces tocarry and preparatory steps than associated with comparative devices.Such advantages are realized, in part, due to the requirement foractivation or launching a smaller mass. In exemplary embodimentsprovided with flexible sears for activation control, the embodimentshave smaller activation forces and larger part tolerances, as comparedto other exemplary embodiments.

The first and second embodiments described above used an exemplarytop-push activation button providing a number of advantages. In yetanother embodiment of the present invention, similar or other advantagescan be achieved using a side-push activation button. That is, instead ofpressing a top or top-mounted button into a device (i.e., toward theskin surface of the user) as described above, the device can beactivated by pressing a button located on the side of the device,potentially molded into the outer barrel cap as shown in FIGS. 38-41 .FIG. 38 is a sectional view of a device utilizing a side-push button inaccordance with a third embodiment of the present invention. The deviceis substantially as described above in regard to the second embodiment,and comprises an outer barrel 112, a slidable inner barrel cap 152 andinner barrel 154 and a base 114. The base 114 comprises at least oneouter barrel retention tab 118 that is configured to rotatably enteropenings in the base 114 and be captured at a rotational position byshoulders 122 of the base 114 as described above. A drive spring 124 anda safety spring 156 are also provided to extend and retract anintroducer needle.

In the third exemplary embodiment shown in FIGS. 38-41 , a side-pushbutton 402 and conforming outer barrel cap 404 and inner barrel cap 406are provided to facilitate a different method of activating the thirdexemplary embodiment. The side-push button 402 is located on the side ofthe device, molded into the outer barrel cap 404, and acts upon theslidable inner barrel cap 152 as shown in FIGS. 38 and 39 , causing theinner barrel cap 152 to slide to the left. That is, the slidable innerbarrel cap 152 comprises an interference side 406 which captures a slotof the needle hub 138 in a first position, and comprises a clearanceside 408 which permits the slidable inner cap 152 to be slide toward theneedle hub 138 and move the interference side 406 from the slot of theneedle hub 138 as shown in FIG. 40 . Once the inner barrel cap 152 hasadvanced to the position shown in FIG. 40 , the slot in the needle hub138 disengages the keyhole slot in the inner barrel cap 152, releasingthe needle hub 138 to drive the catheter assembly 424 into the user'sskin surface. The catheter assembly 424 can be molded as a single pieceor provided with a septum, and can include the septum, introducer needleand catheter, or an in-dwelling catheter.

The embodiment of the present invention can be provided with a skincontacting adhesive layer 115 such as a pressure sensitive adhesive(PSA), and an adhesive cover 117. Precise insertion is achieved byremoving the adhesive cover 117 and securing the infusion set to theinfusion site via the adhesive layer 115, which permits the user toactivate the inserter or place the catheter as described below at theproper alignment and depth. In doing so, the adhesive at or very nearthe insertion site secures the skin surface such that the introducerneedle and catheter, or in-dwelling catheter are driven into the skinsurface in a manner to minimize the risk of tenting at needle insertion.

In the embodiment shown, the button 402 can be a molded-in componentthat drives the inner barrel cap 152 as opposed to a sliding button thathas the keyhole slot molded therein. In doing so, the embodiment ensuresthat the button will not inadvertently become caught on the outer barrel112 when the needle stick protection mechanism is activated. However,other embodiments of the sliding button can have the keyhole molded inas part of the button. Further, these embodiments can be configured towork with these or any other spring-assisted catheter insertion devices,and/or combined with spring-assisted needle stick prevention features.Such a keyhole triggering configuration can be more robust for shippingand handling than a top-push button embodiment. Also, the embodimentaddresses the event where there is a user preference for a side-pushbutton as opposed to a top-push button.

In yet another embodiment of the present invention, similar or otheradvantages can be achieved using a rotary activation button. That is,instead of pressing a top or top-mounted button into a device (i.e.,toward the skin surface of the user) as described above, the device canbe activated by rotating a button located on the device and, by furtherrotation, disengage the inserter, insertion mechanism or module, fromthe base. FIG. 42 is a sectional view of a device utilizing a rotarybutton in accordance with a fourth embodiment of the present invention.The device is substantially as described above in regard to the secondand third embodiments, and comprises an outer barrel 112, inner barrelcap 152 and inner barrel 154 and a base 114. The base 114 comprises atleast one outer barrel retention tab 118 that is configured to rotatablyenter openings in the base 114 and be captured at a rotational positionby shoulders 122 of the base 114 as described above. A drive spring 124and a safety spring 156 are also provided to extend and retract anintroducer needle.

The embodiment of the present invention can be provided with a skincontacting adhesive layer 115 such as a pressure sensitive adhesive(PSA), and an adhesive cover 117. Precise insertion is achieved byremoving the adhesive cover 117 and securing the infusion set to theinfusion site via the adhesive layer 115, which permits the user toactivate the inserter or place the catheter as described below at theproper alignment and depth. In doing so, the adhesive at or very nearthe insertion site secures the skin surface such that the introducerneedle and catheter, or in-dwelling catheter are driven into the skinsurface in a manner to minimize the risk of tenting at needle insertion.

In the fourth exemplary embodiment, the user can use one motion toactivate the device. That is, a rotary motion can be used to activatethe device or inserter of the device, followed by further rotation toactivate the safety of the device, the retraction of the introducerneedle for needle stick protection, and further rotation to detach theinserter from the base. All actions can be implemented using a single,smooth rotation by the user. In this or other embodiments, tactileand/or audible feedback can be provided to indicate needle insertion,needle retraction, safety activation and removal.

In an exemplary embodiment, the button 412 can be rotated about theremainder of the device, being adhesively secured to the skin surface,and in turn, rotate a trigger 414 via the button slot 416 pressing on atrigger tab 418, as shown in FIG. 42 . Activation occurs by rotating thebutton 412 first to the introducer needle and catheter insertionposition, then to the safe position, all in one smooth rotary motion.The drive spring 124 is compressed between the inner barrel cap 152 andthe needle hub 138, and is retained by the needle hub sear engagementwith the inner barrel cap as shown in FIGS. 42 and 43 .

The rotation of the button 412 rotates the trigger 414 via the triggertab 418, and rotation of the trigger 414 rotates a bar-shaped needle hubsear 422. A slot 420 is provided in the inner barrel cap 152 such that,when the bar-shaped needle hub sear 422 is rotated into alignment withthe slot 420, the drive spring 124 will drive the needle hub 138,including the introducer needle and catheter assembly 424, into the skinof the user. Such a rotation triggering configuration can also be morerobust in shipping and handling than a top-push button embodiment, andthe disclosed embodiments address the situation where there is a userpreference for a rotation button as opposed to a top-push button.

Activation of the needle safety, or needle tip shielding, can beachieved by disengaging the tabs in the outer barrel from the base,which also allows removal of the inserter from the base as describedabove. Further, the disclosed embodiments can be used with any number oftriggering modes, such as one wherein the needle hub rotates until themolded-in tabs align with the slots in the inner barrel. Still further,the disclosed embodiments can be configured to work with these or anyother spring-assisted, catheter insertion devices, and/or combined withspring-assisted needle stick prevention features.

FIG. 43 illustrates the drive spring 124 in a loaded state as secured bythe needle hub sear 422 and the inner barrel cap 152. FIG. 44illustrates the needle hub sear 422 and the inner barrel cap slot 420coming into alignment, such that the needle hub 138 will be releasedfrom the inner barrel cap 152, allowing the needle hub 138 to drive theintroducer needle and catheter assembly into the users skin surface.FIG. 45 illustrates the needle hub in a final position after beingreleased from the inner barrel cap.

In these and other exemplary embodiments of the present invention, anumber of features can be provided to prevent premature activation ofthe introducer needle. The following embodiments of the presentinvention describe a number of such features including amanually-activated interlock designed to prevent premature activationand features to prevent separation of the extension set from the base.Such features can include elements for interlocking the outer barrel,hence the integrated/removable inserter assembly, to the base, as wellas the extension set to the base, with variants of the same mechanism.

In such embodiments, there may be a concern that users can accidentallyactivate the needle stick protection mechanism before deploying thecatheter assembly insertion mechanism, thereby rendering the deviceuseless. Additionally, there can be a need to prevent rotation of theextension set top of the devices described above once it has beenattached to the base in order to prevent inadvertent separation of theextension set and base, and interrupting the flow of insulin. A similarfeature to that used to prevent premature activation of the needle stickprotection mechanism can be added to the extension set top to preventseparation of the extension set and base.

FIG. 46 illustrates a locking latch to prevent rotation of elements. Asshown in FIG. 46 , a latch 425 has been added to the outer barrel 12 ofthe embodiments described above. The latch 425 rotates about a moldedpivot point 427 and engages a slot 426 in the base 14, thereby lockingthe two from significantly rotating relative to one another, thuspreventing inadvertent detachment of the inserter and subsequentactivation of the needle stick prevention mechanism.

After insertion of the catheter has been accomplished, and the user isready to detach the inserter, the user can do so by pressing the button428 as shown in FIG. 47 , thereby rotating the latch 425 out of theengagement with the slot 426 in the base 14. Once the latch 425 has beendisengaged from the slot 426, the inserter assembly may be rotated andremoved, at which time the needle stick protection mechanism willactivate and retract the introducer needle from the catheter.

The set top can also incorporate the features described above to securean operational position of the set top or tube set connector. In anexemplary embodiment, the set top can include a latch 435 as shown inFIGS. 48-51 . When the extension set top 432 and latch 435 are broughtinto engagement with the base 14 as shown in FIG. 48 , a chamferedlead-in area 430 can be provided to deflect the latch 435 around thebase 14 as shown in FIGS. 48 and 49 . Subsequent rotation of theextension set top 432 relative to the base 14 will bring the latch 435into engagement with one of the base slots 426 to rotatably secure theextension set top 432 with the base 14 as shown in FIGS. 50 and 51 .When the user wishes to disconnect the extension set from the base,pressure applied to the button 436 of the extension set top will rotatethe latch 435 out of the engagement with the base slot 426, and theextension set top 432 can then be rotated to disconnect it from the base14. A stop 438 can be employed to limit the travel of the button andlatch, such that the molded pivot 440 will not become over-stressed.

The disclosed embodiments can achieve the desired functions of aninterlock described above without additional components and assemblies.However, in these and other embodiments of the present invention,additional parts can be employed rather than molded-in parts and pivotsas shown.

In yet another embodiment of the present invention, such amanually-activated interlock can be designed to prevent separation ofthe extension set from the base in the embodiments described above. Insuch embodiments, there may also be a concern that users canaccidentally rotate the extension set top relative to the base,potentially disengaging the extension set top interlock tabs and allowthe extension set to separate from the base. This can break the fluidpath from the pump, and interrupt the flow of insulin to the patient.Accordingly, embodiments of the present invention can provide asecondary interlock for the extension set top and base in order toprevent disconnection. As shown in FIGS. 52 and 60 , a lock ring 450having one or more lock ring tabs 452, extension set top 455, and a lockring spring 460 can be added to the design to prevent disconnection.

The rotatable lock ring 450 can be provided with lock ring lock tabs 452that are designed to drop into base slots 426 once the extension set top455 has moved into the correct locking position with the base 14. Uponinstallation, the user aligns the extension set top interlock tabs 454with the base slots 426 as shown in FIGS. 52 and 55 , and presses downon the center dome of the extension set top 455 as shown in FIG. 52 .This moves the extension set top 455 down relative to the lock ring 450,which bears on the upper surface of the base 14 as shown in FIG. 52 .Once the extension set top locking tabs 454 are pressed into the slots426 in the base 14, the extension set top 455 and lock ring 450 can berotated until the extension set top interlock tabs 454 lock withshoulders 22 of the base 14, and the lock ring tabs 452 drop into thebase slots 426 as urged by the lock ring spring 460 as shown in FIG. 53. The extension set top 455 and locking ring 450 are now prevented fromfurther rotation, thereby securing the extension set top 455 to the base14 by means of the extension set top interlock tabs 454.

When the user needs to remove the extension set from the base, such aswhen swimming or showering, the user grasps the lock ring 450 and liftsit away from the base 14, then rotates the extension set top 455 untilthe extension set top interlock tabs 454 disengage from the base 14 asshown in FIG. 55 , and removes the extension set. FIGS. 57-59 show thelock ring spring 460 and its retention feature in greater detail, andFIG. 60 is an exploded view of the embodiment. As shown in FIG. 57 , thelock ring spring 460 is held within the locking ring 450 by a retentionfeature that comprises a shoulder 462 on an inner circumference of thelock ring 450. The lock ring 450 is held with the extension set top 455by a retention feature that comprises a shoulder engagement 464 with theextension set top 455.

The disclosed embodiments can achieve the desired functions of aninterlock described above with a more ergonomic interlock between theextension set and the base. In yet another embodiment of the presentinvention, a package 500 as shown in FIG. 61 can be provided thatencloses the integrated/removable inserter, and shields the activationand removal buttons. This allows placement of the device in a mannerthat prevents premature activation of these buttons.

One or more of the above or other exemplary devices can comprise theactivation button 16 on the top of the device, so that when the userplaces the device on the skin prior to activation, there is an ease ofaccess and minimal requirement for dexterity to activate the button.However, in such cases, there is a possibility that the device can beactivated unintentionally, and therefore, a package 500 as describedbelow is used to fully protect at least the buttons 16 and 428 fromactivation during handling and placement of the device.

Accordingly, a package 500 is provided wherein at least the buttons 16and 428 are shielded by the package. The device within the package 500can be provided with a skin contacting adhesive layer such as a pressuresensitive adhesive (PSA), and an adhesive cover as described above. Theadhesive layer cover of the infusion device and the package seal areintegrated into a single, combined adhesive layer/package opening cover504 with a user-graspable pull-tab 505. In addition to sealing thepackage and covering the adhesive of the device, the combined cover 504is used to cover one or more pockets of the package 500 for othercomponents related to filling and dispensing. FIG. 61 shows intransparency a small package 500 for enclosing and shrouding the buttons16 and 428 of an embodiment as described above, and providing large,smooth handling surfaces 502. FIG. 62 shows the device of FIG. 61 withthe package seal and/or adhesive cover 504 removed such that the devicewithin the package can be placed on the skin surface and ready foractivation of the buttons 16 and 428 once the package is removed fromthe device as shown in FIG. 63 . Once the device is adhesively securedto the skin surface, the package can be lifted away.

FIG. 64 is a sectional view to illustrate the device of FIG. 61 ingreater detail, including retention snaps 506 within an opening of thepackage 500 for engaging the device therein and releasably securing thedevice within the package. The snaps 506 can be configured to engage asurface of the device, or can correspond to detents or other profilefeatures of the device contained therein. The exemplary device containedwithin the package can comprise any number of embodiments, such as thosedescribed above. FIG. 65 shows the device of FIG. 64 with the skinadhesive layer 508 exposed after removal of the package seal and/orrelease liner 504 using pull tab 505.

FIG. 66 shows another embodiment of the present invention substantiallyas described above, but further comprising one or more additionalpockets for other components related to filling and dispensing. Thisembodiment comprises a larger package design 510 with the filling anddispensing components in a sample configuration. As noted above, thepackage 510 can also comprise a package seal integrated into a single,combined adhesive layer/package opening cover 514 with a user-graspablepull-tab 515, and retention snaps 516 within an opening of the package510 for engaging the devices therein and releasably securing the deviceswithin the package. FIG. 67 shows the device of FIG. 66 with the packageseal/adhesive release liner removed exposing the adhesive layer 518.

In these embodiments, when the package seal and/or skin adhesive releaseliner is removed, the device can be placed on the skin surface, withoutremoving it from the package, allowing placement without the possibilityof premature button activation. The package retention snaps 506 and 516are incorporated into the package 500 and 510 to maintain the devices inthe package until the user is ready to activate the inserter, at whichtime the user may squeeze the package, such as at a 90 degree anglerelative to the snaps, to open the snaps and allow the package to belifted from the device, leaving the integrated/removable inserter on theuser's skin surface.

As shown in FIGS. 66 and 67 , the package 510 can include one or moreadditional cavities for the insulin reservoir, reservoir filling anddispensing components, and extension set tubing and connections. Byintegrating the package seal and adhesive release liner, the number ofsteps to open the device in preparation for placing the catheter isminimized. Further, in one embodiment, the catheter extension set,reservoir, and reservoir filling and dispensing components, areintegrated into a single package for user convenience. Further, in theembodiment configured as a smaller package, there is a greater ease inplacement. In the embodiment configured as a larger package, there isthe convenience of having all of the components readily available forthe subsequent steps of connecting the infusion pump.

Accordingly, concerns regarding devices having a button on top that maybe prematurely activated during placement of the device on the skinsurface can be minimized. The package further provides a sterile barrierwhich can also serve as the skin adhesive release liner to reduce steps.The package also protects the activation button during placement, afterwhich the package is removed from the device by pressing the sides torelease the undercut snaps. Further, the package can be configured tohouse other elements, for example, the insulin reservoir and extensionset.

Although only a few exemplary embodiments of the present invention havebeen described in detail above, those skilled in the art will readilyappreciate that many modifications are possible in the disclosedembodiments without materially departing from the novel teachings andadvantages of the present invention. Accordingly, all such modificationsare intended to be included within the scope of the invention as definedin the appended claims and their equivalents.

The invention claimed is:
 1. An infusion device, comprising an inserterthat can insert a catheter into a skin surface, comprising: an infusiondevice housing, comprising a catheter and a driver for inserting saidcatheter into a skin surface; an infusion device base for rotatablysecuring said infusion device housing, comprising at least one adhesivelayer for releasably securing said infusion device base with said skinsurface; and an introducer needle and a hub, wherein said hub comprisesat least one sear holding said hub in a retracted position and whereinsaid driver comprises: a push button configured to travel substantiallyperpendicular to said skin surface and deflect said sear of said hubinto a release position, said release position aligning said sear with asear slot.
 2. An infusion device as claimed in claim 1, furthercomprising: a drive spring to drive said introducer needle and saidcatheter into said skin surface when said sear of said hub is deflectedinto said release position.
 3. An infusion device as claimed in claim 1,wherein said driver is configured to release from base and retract saidintroducer needle when rotated.
 4. An infusion device, comprising aninserter that can insert a catheter into a skin surface, comprising: aninfusion device housing, comprising a catheter and a driver forinserting said catheter into a skin surface; an infusion device base forrotatably securing said infusion device housing, comprising at least oneadhesive layer for releasably securing said infusion device base withsaid skin surface; and an introducer needle and a hub, wherein said hubcomprises at least one key holding said hub in a retracted position andwherein said driver comprises: a push button configured to secure saidkey of said hub and comprising a keyhole, said push button configured totravel substantially parallel to said skin surface and align saidkeyhole with said key of said hub in a release position.
 5. An infusiondevice as claimed in claim 4, further comprising: a drive spring todrive said introducer needle and said catheter into said skin surfacewhen said keyhole and said key of said hub are aligned in said releaseposition.
 6. An infusion device as claimed in claim 4, wherein saiddriver is configured to release from base and retract said introducerneedle when rotated.